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Overview:To lead a team-based Manufacturing operation to manufacture low cost, high quality pharmaceutical productsResponsibilities:-Leads day-to-day activities of the Manufacturing team-Develops area Manufacturing plans and measures team performance against goals-Has the ability to work flexible hours/shifts as needed-Assigns resources to meet the Manufacturing schedule on a day-to-day basis- Performs objective technical investigations, including conclusions and recommendations, supporting deviation and investigation reports-Serves as a technical and training resource for the Manufacturing team-Establishes and maintains standards for safety, productivity, costs, and area cleanliness-Writes and implements area SOP’s-Reviews and audits Manufacturing records and documentation-Performs SAP, GXPharma, and Kronos transactions-Troubleshoots and resolves operating/process issues-Coordinates with R&D and Tech Services to schedule equipment SOP and staff readiness and MBR correctness prior to their batches-Coordinates process and cleaning validation requirements for specified products-Interacts with other departments to expedite the Manufacturing process-Develops and implements initiatives to improve quality, cleanliness, safety, and productivity, and to reduce cost-Develops, implements, and monitors training of the Manufacturing teamQualifications:-BA/BS degree (or equivalent), with 3+ years of Pharmaceutical or equivalent experience-Has an in-depth knowledge of the Manufacturing process and equipment (pharmaceutical)-Has proficiency in troubleshooting Manufacturing equipment (pharmaceutical)-Has a knowledge of leading and developing a team-based Manufacturing environment (pharmaceutical)-Has an in-depth knowledge of the regulatory requirements (FDA, cGMP’s, etc.) for pharmaceutical Manufacturing operations-Has a working knowledge of the validation processes-Has a thorough understanding of the documentation and change control processes-Has proficiency in a variety of computer software packages and databases including SAP, GXPharma, Kronos, and Windows-Has a working knowledge of the warehouse and packaging processes-Has the ability to evaluate and edit technical documents-Has excellent oral and written communication skills
-Has the ability to establish and maintain an effective working relationship with team member and other team leaders/team members
•Has the ability to create and foster team spirit, and the ability to develop and coach team members to obtain optimal performance
•Has effective interpersonal and influence management skills in interacting with cross-functional departments (Warehousing, Packaging, QA, QC, etc.)